FDA regulatory foundations
What Is a Medical Device?
A practical FDA screening guide for hardware, software, AI, wellness products, and clinical decision support.
Understand where a product may cross from consumer, administrative, or wellness technology into FDA-regulated medical-device territory.
The FDA starting point: intended use
Under section 201(h) of the FD&C Act, a device is an instrument, apparatus, machine, implant, in vitro reagent or similar article — including software — intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or intended to affect the structure or any function of the body, without achieving its primary purpose through chemical action or metabolism.
The operative word is intended. FDA reads intent from your labeling, instructions, marketing copy, sales conversations, website claims and even the wording on your pricing page. Two products with identical code can land in different regulatory worlds because one says “track your resting heart rate” and the other says “detect irregular rhythms.” Write the intended-use statement before you write anything else, and keep every public claim consistent with it.
Screening outputs on this page are signals for planning, not determinations. Only FDA can classify a product.
Five-step medical-device screen
Work through these steps in order. Each one narrows the question, and a single step can be decisive on its own.
- 01
Write the intended use
State in one sentence what the product is for, for whom, and in what setting. Everything downstream follows from that sentence, including labeling, evidence and class.
A stated medical purpose pushes toward device.
- 02
Check for a disease or condition claim
Does the product reference diagnosis, cure, mitigation, treatment or prevention of a disease, or affect the structure or function of the body? General wellness claims sit outside; condition-specific claims do not.
Naming a condition pushes toward device.
- 03
Characterise the output
Distinguish raw data display from an interpretation. Logging a heart rate is different from flagging a possible arrhythmia, and a ranked differential is different from a specific directive to act.
Interpretation and directives push toward device.
- 04
Identify the user and the setting
A tool for a clinician making a time-critical call in an acute setting carries a different risk profile from a reference tool a consumer reads at home with time to reflect.
Time-critical clinical use pushes toward device.
- 05
Test the software-function exclusions
Check the administrative, records, general wellness, and clinical decision support exclusions in section 520(o), as well as medical device data system status where the product only transfers, stores, converts or displays data.
Failing any exclusion criterion pushes toward device.
A product that clears all five steps is a candidate for non-device status, not a confirmed non-device.
When a non-device becomes a device
Most teams do not set out to build a regulated product. They cross the line by adding a feature or sharpening a marketing claim. These pairs show the most common crossings.
Activity tracker that displays heart rate trends
Same tracker that notifies the user of possible atrial fibrillation
The output changed from data display to a condition-specific interpretation.
Scheduling and billing tool that sequences appointments
Same tool that prioritises patients by predicted deterioration risk
The product now drives clinical management rather than administration.
General health chatbot that summarises public guidance
Chatbot that takes symptoms and recommends a specific treatment
A specific preventive, diagnostic or treatment output defeats the decision-support exclusion.
Image viewer that renders DICOM studies for review
Viewer that segments and flags suspicious lesions automatically
Analysing an image from a device removes the software from the exclusion entirely.
Feature roadmaps change regulatory status. Re-screen whenever claims or outputs change.
Digital-health and software examples
The buckets below reflect how comparable products have typically been treated. They are orientation aids — your specific intended use governs.
Generally not a device
- Practice-management, scheduling and claims software
- Electronic health records used for storage and display
- General wellness apps: sleep, fitness, mindfulness, healthy weight
- Medical reference libraries and clinical education content
- Software that only transfers, stores, converts or displays device data
Likely a device
- Computer-aided detection or triage on imaging studies
- Algorithms interpreting ECG, EEG or other physiological signals
- Dosing calculators that output a specific therapeutic directive
- Continuous monitoring that alarms on a clinical threshold
- Digital therapeutics claiming to treat a diagnosed condition
Needs further analysis
- Risk-prediction models embedded in clinician workflow
- Symptom checkers and triage assistants for consumers
- Large-language-model assistants that summarise patient charts
- Remote-monitoring platforms that combine display with alerting
- Wellness products whose marketing copy drifts toward condition claims
Placement here is illustrative only and is not an FDA classification of any named product category.
FDA tools for deeper research
Once you have a candidate intended use, these primary sources let you test it against how FDA has actually classified comparable products.
FDA Product Classification Database
Search regulation descriptions to find the product code and device class that best match your intended use.
Open source510(k) Premarket Notification Database
Identify legally marketed predicates under your candidate product code and read their intended-use statements.
Open sourceDe Novo Classification Database
Check whether a novel low-to-moderate risk product like yours has already created a classification regulation.
Open sourceDevice classification panels (21 CFR 862–892)
Read the medical specialty panels directly when database search terms do not surface a clean match.
Open sourceClinical decision support software guidance
Work through FDA's criteria and worked examples before relying on the section 520(o) decision-support exclusion.
Open sourceGeneral wellness policy and the Q-Submission program
Confirm your wellness positioning, then use a pre-submission meeting to test classification assumptions with FDA before you build the evidence package.
Open sourceDatabase results are evidence for a screening view, not a classification decision.
Frequently asked questions
Answers here are general education and do not address the specifics of any one product.
Continue your regulatory planning
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This guide is informational only and is not legal or regulatory advice. Confirm any classification decision against current FDA guidance and, where needed, with qualified regulatory counsel.